Patents were knocked out by the Supreme Court—but Myriad is still suing competitors.

For many years, all testing of the BRCA1 and BRCA2 genes in the US was under control of one company: Myriad Genetics of Utah. But many expected that monopoly to be over when the Supreme Court ruled 9-0 that Myriad can't claim patent rights to those genes. In fact, the court ruled, such "isolated" DNA sequences can't get patents at all—although a lab-made form of the gene called the cDNA version still can.

Just weeks after it lost at the high court, Myriad filed new lawsuits against the first two competitors who began offering BRCA gene testing, Ambry Genetics and Gene by Gene. Despite its Supreme Court loss, Myriad believes its competitors are violating at least 10 other patents the company holds related to testing BRCA genes.

Ambry and Gene by Gene use "primers" and cDNA in a way that infringes 10 other Myriad patents asserted in the lawsuit. Those patents are co-owned with the University of Pennsylvania, the University of Utah, and other research institutions.

On Monday, Ambry responded to Myriad's suit and fired off some shots of its own. In its counterclaims, Ambry says that not only are Myriad's patents invalid, but that the Utah company's "bad faith enforcement" of its patents amounts to an antitrust violation.

Now, Myriad is suing Ambry over "patent claims that it knows are invalid under two Supreme Court decisions and Federal Circuit authority," write Ambry's lawyers. The company used publicly funded research to get patents that never should have been granted, then used those patents to "intimidate and chill competition" in the genetic testing markets and deprive patients of access to their own data, according to the counterclaims.

Ambry has committed to depositing the information it gets from testing into public databases, which it says will enable further competition in the testing market. Myriad, by contrast, "is using its invalid patents to maintain as secret patients' gene sequences (which do not belong to Myriad) in an attempt to limit competition."

In its new lawsuit, Myriad describes itself as a pioneering company that spent more than $500 million tracking down the BRCA1 and BRCA2 genes, winning that race in 1994. The discovery was "universally hailed," Myriad's lawyers wrote in a lawsuit. Unless it can use the resulting patents to secure testing profits, Myriad argues, it won't be able to recoup its investment.

In Monday's court papers, Ambry directly takes on Myriad's heroic view of itself. The fight for new approaches to treating breast cancer goes back to the 1980s, when "patients began to mobilize in large numbers to increase government and public attention to the breast cancer epidemic," write lawyers representing Ambry. As a result of widespread advocacy, federal funding of breast cancer research increased more than twentyfold: from less than $90 million in 1990 to more than $2.1 billion in 2008.

Collaboration, not go-it-alone heroism, found BRCA genes

Researchers already knew that a propensity to get breast cancer could be inherited. By 1990 the hunt was on for a gene that could be linked to the disease. Several international research teams were searching; in the US, the two main groups were Dr. Mary Claire King's laboratory at UC Berkeley and Dr. Mark Skolnick's group at the University of Utah.

Collaborations were common among the groups. Skolnick and King themselves collaborated, "but only for a short while because they could not agree on how to conduct the research," Ambry lawyers wrote.

The first evidence of genes linked to hereditary breast cancer came from Dr. King's group. Her lab located the BRCA1 gene on human chromosome 17 in 1990, and the finding was published in Science. The same year, a group called the Breast Cancer Linkage Consortium brought together several different research groups to show that BRCA1 was associated with families that had occurrences of breast and ovarian cancer. The group shared its evidence publicly, and Ambry "is informed and believes that Dr. Skolnick and/or his collaborators attended at least some of those meetings."

Once researchers located the gene on chromosome 17, "standard and well-known techniques could be used to sequence the gene."

At that point, Skolnick and the University of Utah had a big advantage. The brief continues:

His lab had developed a database of an extensive pedigree of Mormon families that contained information on 200,000 families and most of the 1.6 million descendants of the initial 10,000 Utah settlers. Skolnick linked that database to the Utah cancer registry, which resulted in 40,000 cross-linked entries that spurred much of his future research. Although the University of Utah always had control of the database, Dr. Skolnick was in a unique position to utilize it.

Access to this database gave Dr. Skolnick (and later Myriad) an advantage, because it provided the raw natural data Myriad’s team could use to more quickly determine the likely physical location of BRCA1 based on the general chromosome location Dr. King and other groups published.

In 1991, Dr. Skolnick formed Myriad as a spin-off from the University of Utah Center for Genetic Epidemiology with the aim of obtaining additional funding necessary to locate the precise location of the BRCA1 gene.

The whole time, Skolnick collaborated with others: "more than forty researchers from public and private entities," including the University of Utah, McGill University in Montreal, the National Institute of Environmental Health Sciences, Eli Lilly, and Myriad. Skolnick and others published their sequence of BRCA1 in Science on October 7, 1994.

Skolnick also worked with others while pursuing the BRCA2 gene, Ambry notes. For a time, he worked with UK cancer geneticist Michael Stratton; but "Dr. Stratton ended the collaboration after learning that Myriad planned to patent the genes."

Stratton's group, working without Skolnick, announced they had mapped and sequenced BRCA2 in December 1995, and told the journal Nature about their discovery. "The day before the Stratton group's sequence was published in Nature, Myriad announced that it had sequenced BRCA2," writes Ambry.

Myriad began turning its patent claims into a business. "The claim strategy is an overt attempt to convert these natural biological phenomena into patentable inventions using the patent language of a 'method' or 'process,'" wrote Ambry lawyers. In 1996, Myriad set up a $30 million diagnostics lab and began offering a full analysis of the genes for $2,400. The strategy paid off; in the first three quarters of 1997, Myriad earned more than $20 million in revenue, according to the brief.

While the Myriad patents were pending, other labs were screening patient DNA for BRCA1 and BRCA2 mutations. But after the patents were issued, Myriad began threatening—and bringing—lawsuits. Myriad even threatened, and ultimately sued, the University of Pennsylvania, an institution which worked with Myriad to sequence BRCA2.

That behavior gave Myriad a monopoly for years. But in 2009, the ACLU filed suit in New York on behalf of doctors' groups, patients, and breast cancer advocacy groups. The case ultimately went to the Supreme Court, resulting in the June 2013 decision that ruled isolated DNA is not patentable.

Myriad said it is confident its claims will prevail and that Ambry's counterclaims lack merit. "The testing process employed by Ambry infringes 10 patents covering synthetic primers, probes, and arrays, as well as methods of testing related to the BRCA1 and BRCA2 genes," said Myriad. "The claims at issue in this case are not the same as those in the Supreme Court case, which was a separate matter."